BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARTISTE MV

    MDR report key: 5178123 · Received October 26, 2015

    Report

    Report Number
    2240869-2015-05135
    Event Type
    Malfunction
    Date Received
    October 26, 2015
    Date of Event
    September 2, 2015
    Report Date
    September 24, 2015
    Manufacturer
    SIEMENS HEALTHCARE GMBH
    Product Code
    IYE
    PMA / PMN Number
    K103606
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SIEMENS' INVESTIGATION INTO THE REPORTED EVENT IS ONGOING AND A SUPPLEMENT REPORT WILL BE SUBMITTED UPON COMPLETION.

    Additional Manufacturer Narrative · 1

    SIEMENS' INVESTIGATION INTO THE REPORTED ISSUE FOUND THAT THE DEVIATION OF THE FLAT PANEL POSITIONER (FPP) HAD NO CLINICAL RELEVANCE AND PASSED ALL QUALITY MEASUREMENTS. THE ISSUE WAS IDENTIFIED AS A MECHANICAL MISALIGNMENT OF THE FPP. THE FPP WAS CALIBRATED, IS NOW IN TOLERANCE AND THERE HAVE BEEN NO REPORTS OF THE ISSUE SINCE THEN.

    Description of Event or Problem · 1

    THE CUSTOMER NOTIFIED SIEMENS ON (B)(6) 2015, THAT ALTHOUGH THE FLAT PANEL (FPP) IS CALIBRATED, THE POSITIONING WITH OTHER SID'S IN LONGITUDINALLY VERY INCORRECT. DEPENDING ON THE SID IT COULD BE INCORRECT UP TO 15MM. THIS EFFECT CAN ALSO BE OBSERVED WITH THE OTHER LINAC AT THIS CUSTOMER SITE, BUT WITH A DEVIATION OF 9MM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    709541 ARTISTE MV ACCELERATOR, LINEAR, MEDICAL IYE SIEMENS HEALTHCARE GMBH 8139789

    Patients

    Seq Age Sex Outcome Treatment
    1